According to a decision of the United States District Court’s Northern District of California in late June, the Food and Drug Administration (FDA) must publish all proposed Food Safety Modernization Act (FSMA) regulations by November 30, 2013. District Judge Phyllis Hamilton ordered the comment period for the regulations to close no later than March 31, 2014, and all final regulations shall be published in the Federal Register no later than June 30, 2015. FDA was given freedom in issuing the regulations so long as the deadlines were not exceeded. The court decision can be viewed online at www.centerforfoodsafety.org/files/fsma-remedy-order_52466.pdf.
In April, the same court granted the plaintiffs’ (Center for Food Safety and Center for Environmental Health) request for a judicial declaration that FDA had violated the FMSA by failing to promulgate the required regulations in accordance with the deadlines mandated by Congress. The court also found that plaintiffs were entitled to injunctive relief, but left the scope of such relief to be determined following further submissions by the parties, which the court suggested would preferably be in the form of a joint statement setting forth agreed proposed deadlines. The parties, however, were unable to reach an agreement and submitted competing proposals.
The court has sided with the plaintiffs and the court finds FDA’s “target timeframes” to be an inadequate response. Therefore, the court has set the deadlines. The April order can be found online at http://ofwlaw.files.wordpress.com/2013/04/center-for-food-safety-v-hamburg.pdf.
The National Renderers Association (NRA) continues to be confident that the North American Rendering Industry Code of Practice prepares rendering plants well for the impending new regulations.
The regulated industries have been expecting these proposed regulations to be issued for a year. President Barack Obama’s administration seems to be moving slowly because of concern over the cost of the regulations to industries and the economy. In addition, FDA is unlikely to get the large budget increase necessary for hiring new staff to inspect many thousands of food operations that have never before been inspected. In recent conversations with FDA officials, they expect to meet the court deadline of a late November publication.
When the proposed regulations are published, NRA will comment on needed adjustments and will assist FDA in writing guidance for industry and inspectors with the hope that this participation will improve the practicality of expectations and compliance.
August 2013 RENDER | back